February 23, 2023 • 31 mins
Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has manufacturing and product development experience, even aiding in developing combination drug-delivery devices, from startups to Fortune 500 companies, and holds a Project Management Professional (PMP) certification. Etienne has managed cross-functional teams for updating legacy products as well as developing new medical devices. His expansive knowledge, experience, and passion for medical devices are evenly matched with how much he enjoys helping customers work efficiently through the design and development process to bring safe, high-quality products to market.
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Episode Transcript
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Speaker 1 (00:00):
Welcome to the Latin MedTech Leaders podcast, a
conversation with MedTechleaders who have succeeded or
plan to succeed in LatinAmerica.
Please subscribe on yourfavorite podcasting platform.
Apple Podcast, Spotify, GooglePodcast.
Amazon Music is teacher tuning.
I heard radio, Pandora, or theseare
Speaker 2 (00:20):
Welcome to the Latin Metech Leaders podcast, a
conversation with leaders whohave succeeded or planned to
succeed in Latin America.
Today our guest is et Nichols.
Yeah.
I hope I'm pronouncing your namecorrectly.
.
Speaker 3 (00:34):
Nailed it.
Yep.
Speaker 2 (00:35):
, excellent.
A medical device girl andmechanical engineer who loves
learning and teaching howsystems work together.
So et thank you for being in theshow today.
It's a pleasure to have you here.
Speaker 3 (00:47):
Yeah, great to be with you, Julio.
Thanks for, thanks for having meon the show.
Speaker 2 (00:51):
Awesome.
Let's get started.
So, et tell us about yourexperience or your journey to
Latin America.
How is it that you got involvedwith the regional and personal
professional level?
Speaker 3 (01:01):
Yeah, so on a personal note, it, you know,
when I was in college, I had a,a really good friend of mine
whose name was Juan.
He was, uh, from Columbia.
And, uh, I just remember he andI worked, you know, when you're
in engineering school, you worklong hours and then you get up
early to go to work, you just,it's just around the clock.
And we would be at his houseconstantly and his dad, who
couldn't speak English to me,but he would always make the
(01:23):
best milk and, and rice, I don'tknow what it was, but I said,
someday I'm gonna go to Columbiaand I'm gonna eat this in the
country.
Uh, so that's my personal, kindof like, where I was like, oh,
Columbia, I wanna go theresomeday.
Um, uh, professional, we have afew customers that I have
personally worked with in, uh,um, in different places in Latin
America.
(01:44):
Um, one in Columbia, one in, uh,I believe in Brazil.
But, uh, just a f just a fewcustomers that I've interacted
with in Latin America as
Speaker 2 (01:51):
Well.
Excellent.
Very good.
So, um, at the end, let's talkabout trends that you see
happening in the industry thatare relevant to the business of
doing studies in, in, orcommercializing innovation in
Latin America.
Please.
Speaker 3 (02:07):
Yeah, so the thing that, the thing that I go to
when I think about, I mean, youalmost have to look at it
globally.
It's not just, you know, you canfocus on one country over
another and Latin America,certainly, obviously it's the,
there's the focus today, but ifyou look at it globally, what's
happening, U M D R has alwaysbeen, uh, or, or the, the
European market has always been,you know, go there first because
(02:28):
, uh, it's a little bit easierto get to market.
And then eventually you, youbleed over into North America
and, and, uh, and the rest ofthe world.
Uh, the, that's changing with EU M D R.
Um, especially with deadlines.
A lot of the industry has beenexpecting, uh, another shift or
another, uh, delay to thoserequirements.
And I don't think that's reallya safe way to go.
(02:49):
And so it's looking like now,uh, this pendulum has shifted.
So now where people may havebeen trying to be, you know,
first in human in overseas, nowit's looking, looking like, you
know, America is one, one, youknow, north America.
Sure.
But, uh, Latin America is even,is even more, um, appealing
because of the, the increasedtimelines as far as first in
(03:11):
human, some of these clinicaltrials.
Um, and then also some of the,uh, uh, the trends that you see
as far as, um, uh, the cost.
So both timeline and costs are,are hugely appealing when you
look at Latin America comparedto some of the other regions in
the world.
Speaker 2 (03:25):
Totally.
Yes.
What countries, um, did youhear, or do you usually hear
your clients talk about whenthey were thinking about early
feasibility or first humantrials?
Speaker 3 (03:37):
Yeah, that's a good question.
Um, I don't have a specificcountry, um, you know, that
comes to mind as far as thatgoes.
Um, it, lately I've just beenhearing about the shift, uh,
shift more away from theEuropean market.
Speaker 2 (03:49):
That's true, that's true.
Um, and, and, and also I wouldsay that, uh, I just met with,
uh, sponsor the ceo, e o formedical device company, uh, is a
company, uh, out of, um,Seattle, Washington.
And, uh, it's just shocking how,um, unsatisfied he is with the
(04:13):
FDA ID approval process for a,an early feasibility study.
And then the word he used wasuncertainty.
Uncertainty is the enemy of astartup.
You cannot have uncertainty.
You, you can have risk ofcourse, but not uncertainty.
And there's so much uncertaintyin Europe, of course, as you
correctly said.
And there's so much uncertaintyin the US as well.
(04:36):
So that's probably the reasons,the main reason why companies
are looking at other places likeColumbia, et cetera, to do early
visibility
Speaker 3 (04:43):
Work.
Yeah.
And, and I know, I mean, I seeyou, Julio is kind of the expert
as far as Latin America as awhole.
There's certain things that I, Iknow about the different regions
of different things, but, um,I'd love to hear, I, I don't
wanna flip this aroundnecessarily, but I'd love to
hear some of the things like youas specifically say, Hey, this
region, you know, maybeColumbia, but just because, you
know, that has part of my heartthere, um, you know, some of
(05:06):
the, the things as far as theuncertainty, cuz because I
latched onto that word,uncertainty.
Why would, uh, you know, whatare, what are your thoughts as
far as, uh, you know, the flipside, um, in Latin America?
Speaker 2 (05:17):
Yes.
Yeah.
The, the way it works, theapproval process, uh, the way it
works in a country like Columbia, for example, and I'm Colombian
as well, so I'm, I'm biased, uh,and we do most of our work in
Colombia.
But I've, I've analyzed prettymuch the whole region, pretty
much the whole region.
I just finished an article about, uh, comparing the regulatory,
(05:40):
regulatory approval process inColumbia, Mexico, and Brazil.
And, uh, it, it is, I mean, ifyou put the three countries
together, the timelines, theprocess, I mean the steps, the
review cycles and all that, Imean, it's just obvious that
Columbia is perhaps the mostappealing country and the
country that offers the mostcertainty to these companies.
(06:02):
And that's what they're lookingfor, uh, without mentioning cost
savings and, and, uh, patientrecruitment potential because of
the size of the, uh, of thecountry, the population.
So I, I will say that, uh, LatinAmerica is getting more and more
mature, uh, countries likeColumbia, like Chile are really,
(06:23):
really making efforts to, tobecome, uh, knowledge economies
versus, uh, commodity exportingor agriculture exporting
countries.
And, and knowledge economiesmeans that you have to, to, to
somehow connect, uh, yourindustries to the world,
especially the service industry,uh, in, in, in the clinical
(06:47):
research is a great, it's just afantastic way of, of connecting
a country to the world to highlevel of, of, of, uh, knowledge
about innovation and all that.
So, so yeah, I will say that,uh, Columbia is offering a lot
more certainty, way morecertainty than Europe or the
United States right now.
Speaker 3 (07:07):
Yeah, absolutely.
Yeah, it's a good summary.
Speaker 2 (07:10):
All right.
So let's, uh, continue.
Um, I heard that, uh, you guysdid a great survey about the
state of the industry.
I'm just so thrilled to, to to,to have you here and to, uh,
speak about it.
I mean, can you elaborate onthat, where you guys, uh, what
you guys, uh, concluded afterreading all those surveys?
answers?
Yeah.
Speaker 3 (07:30):
Yeah.
And, and so yeah, we did do asurvey.
We called it the, uh, qualitymanagement and product
development surgery survey, um,uh, the 2022 State of MedTech.
And, uh, you, there were, therewere several, several things
that came out of it.
I guess I should start bysaying, we interviewed 519
quality professionals.
Um, and so when I say 519, um,about 60% of those were quality
(07:54):
and regulatory clinical.
Um, about 26% of those wereproduct development or
engineering.
And then we had a, a smallsliver of manufacturing, and
then, uh, about 11% worthcorporate or executives.
So the majority were quality andregulatory.
Um, that survey, uh, it, itcovered a broad range of topics
and you asked about conclusions,so we'll talk about in just a
minute.
(08:15):
Um, but I also wanna say, weactually just, I think we just
closed, uh, our most recentsurvey as well.
So we, we have about 600 thistime, uh, quality professionals
that we have interviewed.
So we're getting ready for, fornext year.
So that'll be coming up.
Um, we'll definitely let youraudience know when that's out.
As far as the, uh, theconclusions, there were some
(08:36):
interesting findings.
And before I get to conclusions,one of the things that really
stood out was that timing reallymatters.
And, uh, um, to your point withColumbia, um, that's, that's the
thing that I noticed when Italked to, when I looked at the,
the timelines between Brazil,Mexico, and, and Columbia.
Just the, uh, the speed at whichyou could expect to get through
(08:57):
with Columbia was, was prettymind boggling compared to some
of the others.
Um, I mean, it's almost an orderof magnitude, isn't it?
You know, the difference, um, sowhen we looked at the different
classes, so, so class one, classtwo, class three for class three
device, um, on average, well, Idon't know if it's really fair
to take an average, but let,let's use percentages.
(09:19):
The bulk, 47% of, uh, uh, classthree devices, um, for the FDA
took three to five years to getto market.
So that's actually probably alittle bit, I mean, that
actually might even be a littlefast compared to what I was
expecting.
Um, about 23% of those expected,you know, they, they were around
two to three years, um, but themajority are expecting to, to
(09:43):
take longer than five years.
So if you can shave a fi a yearoff of that, totally.
Yeah.
Yeah.
I mean, you sha you, you nowhave 20% faster to market.
20% is huge.
So, um, just timing, timingmatters, you know, and, and we
heard that from several, uh,several different tiers, um,
MedTech professionals as far as,you know, the different things
(10:05):
that we, we heard.
We, um, another thing that welooked at was whether or not,
uh, these medical professionalswere using what kind of tools
they were using, whether they'reusing purpose-built solutions or
, um, you know, uh, just generalpurpose tools.
It was about half and half.
And when we looked at that, theones who were not using, uh,
(10:26):
purpose-built solutions, youknow, something that was
specifically built for theirindustry, um, timing, uh, timing
was affected as well.
So that was interesting.
Um, let me, I'll kind of skip tothe end as far as some, the, the
top four things that we sawhappening.
So as far as, um, uh, the thingsthat we saw was a disconnect
(10:49):
between management and quality,the actual quality, uh,
department.
So there's a disconnect as faras whether or not, um, they were
actually on target or excellingin quality.
So management typically said,no, we're not doing well with
quality.
It was kind of like a, um, uh,the, the majority of them,
(11:10):
whereas a lot of qualitymanagement said, we're doing
pretty good.
So there was a little bit of adisconnect there.
So that was interesting.
You know, something that tothink about, um, when we kind
of, when we kind of did a fewinterviews with some different
people as to why might that bethe case, uh, one of the
thoughts was, well, managementis thinking about two different
things.
You know, the quality may bethinking how many CAPAs are
(11:31):
open, how many CAPAs have beenclosed, uh, whereas quality in
the, the, the upper executivesmight be thinking more along the
lines of something like, um, youknow, how fast are we getting to
market?
Have we produced more revenue?
And, and, you know, what's theoutlook look like?
So that was one of the thingsthat we noticed.
Uh, supplier management wasanother one.
And, um, and I don't know, I, I,again, I, I love hearing from
(11:54):
you Toolio, you know, I know youwere all on our podcast.
And so when I think suppliermanagement, uh, that's one of
the things that I love to, tohear about as far as, you know,
the, the Latin America and howyou've seen some of those
supplier, um, you know, just cuzMedTech companies are gonna call
it a supplier, whoever they are.
But that partnership, um, acrossthose country lines, what have
(12:16):
you seen as far as thatmanagement?
Speaker 2 (12:18):
Well, um,
Speaker 3 (12:20):
Is that something I'm, I'm allowed to ask
Speaker 2 (12:22):
?
No, no.
Uh oh, it's a good question.
I don't know the answer to behonest with you.
I, I, yeah, I don't, I don't getinvolved.
We don't get involved in, in, inquality issues with our clients.
They just ask us for SOPs, andthat's it.
I mean, we're a US company, sowe are not really, so, no, I
(12:46):
don't, I don't have an answerfor that, to be honest with you.
I'm
Speaker 3 (12:48):
Sorry,.
Well, so No, no, that's okay.
And that's okay.
I just like to ask the question.
I don't mean to put anyone onthe spot.
I'm supposed to be the one onthe spot here,.
Speaker 2 (12:55):
So,
Speaker 3 (12:57):
Uh, one of
Speaker 2 (12:58):
Speaker 3 (12:59):
Anyway.
Well, you know, when, when Ithink supplier management, you
know, we're going to a remoteworld, you know, and, and that's
inevitable.
But when you talk about certainaspects of your suppliers, there
are certain things that you needto be doing in person.
And I'm, yeah, this is me alittle bit selfishly as a, as a,
as a, you know, a world traveler, traveler, not necessarily by
choice.
My wife has turned me into one.
(13:19):
She, she takes me differentplaces.
And, and that's wonderful.
I'm very thankful for that.
Um, when you choose yoursuppliers, you know, one of the
things you need to think aboutis how close are they?
How can I, can I get to them?
Um, you know, can I have arelationship with them?
And, uh, so you don'tnecessarily think of a country,
you know, at least I don'tnecessarily think, is this
country a place I wanna go tofor that supplier?
(13:40):
But that actually plays into it,um, your relationship with those
things.
So that might be another thingto think about when you're
thinking about your, your longterm
Speaker 2 (13:47):
Suppliers.
Yeah, that, that's a greatpoint.
That's a great point.
And, and, and of course, uh, weoperating in Latin America, and
one of the things from theget-go, we started the company,
we set it up as a UScorporation.
We are a Florida based company.
And that's also to, to give ourclients that level of trust that
(14:08):
you're, they're dealing with alocal supplier, they're dealing
with a US company.
We're a real people in the us.
We're not some remote company inColumbia with a bank account
with a Swift number that takeswhole page,,
Speaker 3 (14:22):
Right?
Speaker 2 (14:23):
I mean, a whole page of wiring instructions.
You don't know if you're gonnaget your money, these people.
So, so, yeah.
So, so, so, no, it's a greatpoint.
And the word that buffer betweenour clients and our research
centers, uh, not our researchcenter.
I mean, the hospitals that wedeal with are in our network of,
uh, research centers, um, sothey don't have to deal with
(14:46):
foreign suppliers.
So we make it easier for ourclients in, in that way.
Yeah,
Speaker 3 (14:51):
Yeah.
Yeah.
So that's one of the things that, uh, you know, so supplier
management just in general wasone of the things that, um, we
saw quite a few people reallyfelt like was below average.
So actually 75%, 75% felt liketheir supplier quality
management program was belowaverage, or average or below
average.
(15:12):
So that was something to thinkabout.
Um, and, um, yeah, it's just oneof the things that you need to
think about.
Um, another thing to thinkabout.
So one of the other issues withour, you know, when, with that
we found in this survey was oneof the, uh, um, one of the
things that people experience isif you experience a warning
(15:33):
letter, it may take three yearsto reach resolution for that.
Now, I'm, I come from thequality regulatory side, so I, I
think a lot about the quality.
Um, uh, so that's, that's one ofthe things that, um, again, uh,
that uncertainty and starttying, tying it back to that
word that you said, you know,certainty that what you have as
a quality product, what you haveis something that you, uh, you
(15:55):
know, what is going to meet yourexpectations, um, that's
important in the quality world.
Um, because if you, if you don'tcut corners, if things don't
work out the way you expect themto and so forth, um, yeah,
those, those warning letters cantake a long time to resolve.
Yeah,
Speaker 2 (16:09):
Yeah.
I'm sure.
All right.
So, so basically, um, the issueof time is probably the, the,
the issue that we can all helpin Latin America, uh, or the
issue with Latin America can,can, can play a, a predominant,
uh, role for the MedTechindustry, uh, as you correctly
(16:30):
found.
And that's, that's also my, it'sbeen my experience.
That's usually what I hear.
I mean, time, time, time.
How can we start this trialfaster anywhere in Latin
America?
Sometimes I have conversationwhere I have to give them the
whole, my potential client, thewhole framework around the
(16:51):
different countries so that theycan understand where to go and
where they can get their studyapproved faster.
So, so, yeah.
Yeah.
Um, the other thing that I, thatI, I'm very thrilled about is
your acquisition of, um, smarttrials.
Smart trials.
Yes.
That will also save time and,and, and effort in managing
(17:14):
these smaller medical deviceearly disability studies, which
are different from pharmastudies.
So, uh, I think, uh, thepartnership that we have and,
and what we're putting togetherhere is gonna benefit the whole
industry, uh, because we'regonna, uh, uh, solve one of
their pain points.
One of the problem is, which isthe time to take that takes a
(17:37):
device to get to market.
Speaker 3 (17:39):
Yeah.
Uh, not just the time too, butlike you said, the certainty.
Um, the
Speaker 2 (17:43):
Certainty.
Exactly.
Speaker 3 (17:44):
Yeah, exactly.
When you have, uh, clinicaltrials spread over multiple
locations, and, uh, you'retrying to capture all that data,
whether it's on paper orthrough, you know, just however
that's being captured, um,really a solution like smart
trial is, is really the way togo as far as that electronic
data capture.
I mean, it's just, it willincrease your, your certainty
(18:04):
and your ability to, um, justhave a lot of more confidence
in, in what you're actuallyperforming.
So,
Speaker 2 (18:11):
Yes.
Yes.
And, and I guess now with theacquisition of smart trials, uh,
your survey may change a littlebit, may add different questions
or, right, yeah.
Speaker 3 (18:23):
Related
Speaker 2 (18:23):
To clinical research, because, uh, it is really hot
topic nowadays.
Uh, the, the increase in demandthat I, that, uh, that I've seen
this year as beingunprecedented,
Speaker 3 (18:35):
I, I think something I, and I'm curious to see how
it's changed.
I remember one of the numbersfrom your articles actually was,
uh, the increase, what from 2012to 2017 was like 94% increase.
Wasn't that that,
Speaker 2 (18:47):
Right, exactly.
Yes.
And
Speaker 3 (18:48):
That's five years old, so
Speaker 2 (18:50):
Yeah, yeah, yeah.
I mean, every, every week I, Iget at least three new inquiries
in our website about a new studyin, in Latin America.
So definitely there is, there isan issue happening in the United
States.
There's an issue happeningEurope that is, there's a
bottleneck somehow also becauseof Covid, uh, probably because
(19:12):
there is, there is, um, newinvestors who knows what
really go this, but it'sprobably a combination of
factors and, and, uh, certainlyLatin America has become a place
to, to, to
Speaker 3 (19:26):
Yeah.
Speaker 2 (19:27):
Help fix this issue of timing.
Yeah,
Speaker 3 (19:29):
Exactly.
That's, that's, you know, it'sfunny, we, we think about the
development of a, you know, amedical device and how much, uh,
you know, a chunk of thatclinical trial is, you know, the
cost of developing that medicaldevice.
You know, some, some studies, Ithink it's, you know, not quite
half per half, uh, the amount ofcost.
(19:50):
But you know, in the,historically it's been in the 30
to 40% range, I think, you know,that's, that's the amount of
money it takes to develop amedical device, um, to put it
through clinical trial.
Um, if I'm not mistaken, youknow, that some of the things I
think I are have been read fromyou, though, you know, are, you
know's like 60% reduction incosts as those
Speaker 2 (20:12):
Clinical trials up to, yes.
I would say, yeah, that's, that,that's, that's kinda accurate.
Um, anywhere between 30 and 60%,I would say.
Uh, I see, uh, especially inColumbia, uh, with the Columbian
peso at a historic, uh, lowversus the US dollar.
And, um, it's just, uh, reallyunbeatable to, to, uh, as a
(20:39):
country, I mean, to buy servicesfrom a hospital in Columbia,
you're gonna get a, a greatbargain, uh, is the second most
value currency after Venezuelaand Argentina, Venezuela were
obvious reasons.
Argentina is a country that isstruggling so much to, to get
ahead, and it's very, uh, yeah,unstable in many ways,
economically, politically, uh,socially, uh, but inflation in
(21:03):
Venezuela and Argentina are just, uh, really, really difficult.
It's, it's, it's just funny.
Um, you, you, you walk thestreets of, uh, Colombia in
Bogota, and, uh, there arepeople selling crafts on the
streets with Venezuelancurrency.
They, they sell hats and theysell purses,, they make
(21:25):
animals.
You can, oh, really?
.
Oh my goodness.
That's how bad.
It's, the issue with clinicalresearch in Venezuela is
interesting.
I'm involved with a hospital inCaras, probably the largest
private hospital in, in, in, inVenezuela.
And, um, we are doing a studywith a, uh, intervention of
(21:48):
cardiologist, one of the top inLatin America.
He's from Caras, and he works atthe hospital, and we're working
on a couple studies in Columbia.
And, uh, he's a proctor of thesponsor for the Saudi Columbia.
And we talk a lot, uh, aboutdoing studies in Venezuela.
But the issue is that Americanscannot travel to Venezuela.
(22:09):
But, uh, Venezuela could be anideal place for clinical
research if American could getvisas and travel to the country,
because it's a, it's a countryof over 45 million people,
something like that.
Uh, Columbia is 53 now, uh, and,um, it's a country that has a
great infrastructure, privateAli Ali, the public
(22:29):
infrastructure is gone.
There's really no private, uh,there's no, there's really no
universal healthcare system oranything like that.
It's all private.
You have to have money.
It's dollarized.
So, so yeah, prices are probablynot as cheap as Columbia, but,
uh, it could represent greatsavings for companies.
And eventually the issue will befixed.
I mean, Americans willeventually be able to travel to
(22:51):
Venezuela.
And, uh, actually the pioneer ofearly feasibility clinical
research in Latin America wasVenezuela, Dr.
Corrado, Caras, like 20 yearsago.
Yeah.
Speaker 3 (23:03):
And you know, when I was first thinking about this,
um, first inhuman and some ofthe clinical trials, uh, one of,
one of the issues that I kind ofthought, well, what about
recruitment?
You know, is it, uh, trulyrepresentative of the same type
of population you might see in a, in America, um, whether it's
diet based, things like that.
And, um, just the abil the, thecountries, you know, really
(23:26):
impressive as far as, you know,having not been there myself,
just the things that I've readand the things I've learned
about it, um, it, it's, it's toa level where, you know, the
same, very similar, um,different stratas of life, I
guess different tier, whetherit's diet or, and so forth.
So, um, that kind of erased oneof the biggest concerns in my
mind when it came to, uh, youknow, clinicals and actually was
(23:48):
a big convincing factor, youknow, in, in my mind that, that
it would be a, an appealingplace to go.
Speaker 2 (23:53):
Exactly.
Yes.
Yeah.
Yeah.
Latin America is veryAmericanized nowadays and, and
hospital infrastructure, the waypeople practice medicine and,
and the lifestyle is veryAmericanized.
And, and, uh, it's just like inthe US it's a mix of cultures.
Yeah.
I mean, countries like, uh,Argentina, I mean, probably the,
(24:15):
the population, uh, mix is, is,is uh, is very similar to the
United States, uh, very European, uh, influence.
And, uh, Colombia is a greatmix.
It's a little bit of everything.
You have Italians, uh, Germans,uh, of course Spanish, uh, in,
(24:38):
in Colombia you have also Asiancommunities.
You have Middle Eastern, uh,population.
So it, it kind of similar to, tothe US in, in a way, and, and,
and whites in the US arebecoming minority.
Speaker 3 (24:50):
Yeah, it's true.
It's true.
Speaker 2 (24:53):
It's funny,
Speaker 3 (24:53):
it just,
every, every, everything's
cyclical.
It's just, yeah.
Speaker 2 (24:56):
Yeah.
Exactly.
Speaker 3 (24:58):
Um, so I'm curious about, so you heard kind of my
personal anecdote at thebeginning about, you know, maybe
Columbia or whatever.
I'm curious, um, uh, if youcould tell me your quick snippet
as to why, you know, I should goto Columbia?
Maybe not even necessarily froma clinical standpoint.
I just, um, you know, havingbeen there, you know, the, the,
a native yourself, I'd just loveto hear what you have to say
about it real quick.
Speaker 2 (25:18):
Uh, about what, excuse me about going to
Columbia.
Speaker 3 (25:20):
Yeah.
Just, you know, one of the,like, okay, I'm just imagining I
get off the plane and I'm goingto the hospital, but maybe I
want to do something else.
Oh, I see.
What do you recommend?
What should I do first?
Oh,
Speaker 2 (25:32):
Oh, oh, oh,
Speaker 3 (25:33):
I see, I see.
On a personal note.
Speaker 2 (25:34):
Yeah, on a personal note, well, I, if you go to
Columbia, you have to visitBogota is perhaps one of the,
the, uh, the largestmetropolitan areas of, uh, Latin
America with Mexico City, with,uh, Sao Paolo Buenos airs.
It's kinda at the same level.
(25:54):
Uh, you get out outta theairport, and first of all, the
first, one of the best airports,if not the first, uh, there's a
recent survey on this, um, is inBogota.
El Dorado Airport is perhaps thebest airport in, in, in Latin
America right now.
And, uh, that's a lot to say,but it's, it's brand new, just
(26:14):
impressive airport.
And, um, and the highway thatyou see is really, really
impressive.
It is not, I mean, you feel thatyou are not in a banana
republic, or you feel that youare in a real country.
, right.
.
Right.
And, um, of course, Bogota is acapital city.
And, uh, Bogota is, uh, a placeof about over 10 million people.
(26:40):
It's a large metropolitan area,and, uh, it has one of the best
hospitals in Latin America.
And, uh, the reason for that isbecause the geographic location
of the country is, is kind ofprivilege.
Cause it's, it is the firstcountry in South America, so it,
it, it, everybody from theCaribbean travels to Columbia
(27:01):
for medical care, for advancedmedical care.
Everybody from Central America,Panama, Costa Rica, Hondura,
Nicaragua, they either, eitherchoose to go to Mexico or
Colombia.
Right.
And everybody from the south,everybody from Ecuador or Peru,
uh, well, not so much Peru, butunless you're in the, uh,
(27:23):
northern part of Peru.
But, uh, Ecuador, um, Bolivia,they all travel to Columbia for
medical care.
So, so yeah, it's, um, I wouldsay Bogota managing is a
fascinating city.
Very metropolitan, verymulticultural.
And, um, the other city that isup and coming is perhaps the
(27:45):
fastest growing city in Latin,in, in Columbia, probably one of
the fastest growing cities inLatin America is Barran.
Barran is the largest city inthe whole Caribbean basin after
Miami.
That's a fact that not manypeople know about.
Wow.
So yeah, it's a city of abouttwo and a half, 3 million
people, but it, the area ofinfluence of Barran is about 10
million people.
(28:05):
Cause it covers the wholeCaribbean coast's, the largest
metropolitan area next to, andit's right in the middle.
Um, Santa Marta, it's a smallercity towards the north, and cor,
which everybody knows about, istowards the south.
But, um, Barran is the center,the economic center of the
Columbia, Caribbean coast, andhas a large number of hospitals.
(28:27):
I will say probably there areabout at least 10 high
complexity hospitals in thecity.
So patient recruitment is great.
Speaker 3 (28:34):
That's, that's fantastic.
You know, I, um, community isone of the things that I don't
think about, I don't know thatwe think a whole lot about in
MedTech, you know, just thecommunity in general.
Um, the MedTech itself is kindof a small industry, uh, but if
you go to someplace that's, youknow, I don't know if you try to
go to the Mayo Clinic orwherever else where you're not,
you know, listened to andperhaps at whatever level you're
(28:57):
at, what I'm curious about is,you know, the different
communities within thosehospitals and the ability to, to
have a better relationship withthose.
Um, you know, you, you're kindof a, you, you, you work between
the US and, uh, and, anddirectly with the hospital.
So I'm sure you see and manage alot of that relationship.
But, um, that's one of thethings that I'm interested in
learning a little bit more abouttoo in the future.
(29:17):
Yes.
Speaker 2 (29:18):
So, yes.
Yes, exactly.
, and, you know, I mean,uh, I, I'm always very, they
about the possibilities ofbringing your technology to
Latin America.
There are, uh, a lot of, um, uh,there are a few hubs of
innovation in the region, andmedical devices are increasingly
now that we can use software asa medical device, you find a lot
(29:42):
more entrepreneurs trying, uh,to do something in this area.
So it's a, it's a, it's a, it'sa slowly growing industry in
Latin America.
I would say Brazil, Columbia, Imean, the, the top five
countries in the region have theneed of a software like, uh,
green, like rural offers qualitymanagement system.
So, so yeah, it would befantastic to translate this
(30:04):
offer to Spanish.
I don't know, uh, if you guyshave plans to do that, but
that's a growing
Speaker 3 (30:09):
Area.
That's fantastic feedback.
Um, yeah, that's, that's areally good point.
I don't know that we do at themoment, but I, I need to check
with my product team.
I should probably keep my mouthshut until I know for sure.
Um, but tho like I said, youknow, if, and I'll, I'll send a
link to that, um, state of 2022report, um, and then eventually
when we have our state of 2023report release, we can, we can
(30:30):
definitely send that your way aswell.
But one of the things that, thatwe saw that I already mentioned
was, uh, just the, the companiesthat don't use those specific
tools, um, to help them get tomarket, whether it's something
like Green Light Guru or smarttrial for their clinical trials,
uh, they, they're moving slowerthan the ones who are, who are
(30:50):
using those purpose-built tools.
And Yeah.
Uh, you know, um, I, I look atit kind of like, you know, as a
mechanical engineer, if I lookback at my past, I, I had the
privilege to work at a companywhere, um, it was a hundred year
old company.
It was in the steel industrybefore I came to MedTech.
Uh, we had four different waysof keeping our drawings.
You know, we had, we had them onpaper.
(31:12):
The, you know, the, the, I can'tremember.
It's a E two, just the massivepieces of paper that people had
hand drawn, which is fantastic.
Um, we had microfilm, we hadindex ideas, and then we had
solid works.
You know, guys like me are like,why are we not using solid works
for everything?
Look, I can do what you do fourdays in five minutes.
And, uh, it's just kind of theway the world, you know, it's
always changing.
(31:33):
And, you know, the companiesthat embrace that change, they,
they just move faster.
So.
Totally.
I agree.
Yeah.
Speaker 2 (31:39):
All right.
At the end, we are close to theend of the show.
Thank you so much for beinghere.
It was a delightfulconversation.
I look forward to being intouch.
Speaker 3 (31:46):
Yeah, fantastic.
Great talking to you, Julio.
Speaker 2 (31:48):
Bye-bye.
Thank you.
Speaker 3 (31:50):
Take care.
Take care.
Welcome to the Latin MedTech Leaders podcast, a
conversation with MedTechleaders who have succeeded or
plan to succeed in LatinAmerica.
Please subscribe on yourfavorite podcasting platform.
Apple Podcast, Spotify, GooglePodcast.
Amazon Music is teacher tuning.
I heard radio, Pandora, or theseare
Speaker 2 (00:20):
Welcome to the Latin Metech Leaders podcast, a
conversation with leaders whohave succeeded or planned to
succeed in Latin America.
Today our guest is et Nichols.
Yeah.
I hope I'm pronouncing your namecorrectly.
Speaker 3 (00:34):
Nailed it.
Yep.
Speaker 2 (00:35):
A medical device girl andmechanical engineer who loves
learning and teaching howsystems work together.
So et thank you for being in theshow today.
It's a pleasure to have you here.
Speaker 3 (00:47):
Yeah, great to be with you, Julio.
Thanks for, thanks for having meon the show.
Speaker 2 (00:51):
Awesome.
Let's get started.
So, et tell us about yourexperience or your journey to
Latin America.
How is it that you got involvedwith the regional and personal
professional level?
Speaker 3 (01:01):
Yeah, so on a personal note, it, you know,
when I was in college, I had a,a really good friend of mine
whose name was Juan.
He was, uh, from Columbia.
And, uh, I just remember he andI worked, you know, when you're
in engineering school, you worklong hours and then you get up
early to go to work, you just,it's just around the clock.
And we would be at his houseconstantly and his dad, who
couldn't speak English to me,but he would always make the
(01:23):
best milk and, and rice, I don'tknow what it was, but I said,
someday I'm gonna go to Columbiaand I'm gonna eat this in the
country.
Uh, so that's my personal, kindof like, where I was like, oh,
Columbia, I wanna go theresomeday.
Um, uh, professional, we have afew customers that I have
personally worked with in, uh,um, in different places in Latin
America.
(01:44):
Um, one in Columbia, one in, uh,I believe in Brazil.
But, uh, just a f just a fewcustomers that I've interacted
with in Latin America as
Speaker 2 (01:51):
Well.
Excellent.
Very good.
So, um, at the end, let's talkabout trends that you see
happening in the industry thatare relevant to the business of
doing studies in, in, orcommercializing innovation in
Latin America.
Please.
Speaker 3 (02:07):
Yeah, so the thing that, the thing that I go to
when I think about, I mean, youalmost have to look at it
globally.
It's not just, you know, you canfocus on one country over
another and Latin America,certainly, obviously it's the,
there's the focus today, but ifyou look at it globally, what's
happening, U M D R has alwaysbeen, uh, or, or the, the
European market has always been,you know, go there first because
(02:28):
, uh, it's a little bit easierto get to market.
And then eventually you, youbleed over into North America
and, and, uh, and the rest ofthe world.
Uh, the, that's changing with EU M D R.
Um, especially with deadlines.
A lot of the industry has beenexpecting, uh, another shift or
another, uh, delay to thoserequirements.
And I don't think that's reallya safe way to go.
(02:49):
And so it's looking like now,uh, this pendulum has shifted.
So now where people may havebeen trying to be, you know,
first in human in overseas, nowit's looking, looking like, you
know, America is one, one, youknow, north America.
Sure.
But, uh, Latin America is even,is even more, um, appealing
because of the, the increasedtimelines as far as first in
(03:11):
human, some of these clinicaltrials.
Um, and then also some of the,uh, uh, the trends that you see
as far as, um, uh, the cost.
So both timeline and costs are,are hugely appealing when you
look at Latin America comparedto some of the other regions in
the world.
Speaker 2 (03:25):
Totally.
Yes.
What countries, um, did youhear, or do you usually hear
your clients talk about whenthey were thinking about early
feasibility or first humantrials?
Speaker 3 (03:37):
Yeah, that's a good question.
Um, I don't have a specificcountry, um, you know, that
comes to mind as far as thatgoes.
Um, it, lately I've just beenhearing about the shift, uh,
shift more away from theEuropean market.
Speaker 2 (03:49):
That's true, that's true.
Um, and, and, and also I wouldsay that, uh, I just met with,
uh, sponsor the ceo, e o formedical device company, uh, is a
company, uh, out of, um,Seattle, Washington.
And, uh, it's just shocking how,um, unsatisfied he is with the
(04:13):
FDA ID approval process for a,an early feasibility study.
And then the word he used wasuncertainty.
Uncertainty is the enemy of astartup.
You cannot have uncertainty.
You, you can have risk ofcourse, but not uncertainty.
And there's so much uncertaintyin Europe, of course, as you
correctly said.
And there's so much uncertaintyin the US as well.
(04:36):
So that's probably the reasons,the main reason why companies
are looking at other places likeColumbia, et cetera, to do early
visibility
Speaker 3 (04:43):
Work.
Yeah.
And, and I know, I mean, I seeyou, Julio is kind of the expert
as far as Latin America as awhole.
There's certain things that I, Iknow about the different regions
of different things, but, um,I'd love to hear, I, I don't
wanna flip this aroundnecessarily, but I'd love to
hear some of the things like youas specifically say, Hey, this
region, you know, maybeColumbia, but just because, you
know, that has part of my heartthere, um, you know, some of
(05:06):
the, the things as far as theuncertainty, cuz because I
latched onto that word,uncertainty.
Why would, uh, you know, whatare, what are your thoughts as
far as, uh, you know, the flipside, um, in Latin America?
Speaker 2 (05:17):
Yes.
Yeah.
The, the way it works, theapproval process, uh, the way it
works in a country like Columbia, for example, and I'm Colombian
as well, so I'm, I'm biased, uh,and we do most of our work in
Colombia.
But I've, I've analyzed prettymuch the whole region, pretty
much the whole region.
I just finished an article about, uh, comparing the regulatory,
(05:40):
regulatory approval process inColumbia, Mexico, and Brazil.
And, uh, it, it is, I mean, ifyou put the three countries
together, the timelines, theprocess, I mean the steps, the
review cycles and all that, Imean, it's just obvious that
Columbia is perhaps the mostappealing country and the
country that offers the mostcertainty to these companies.
(06:02):
And that's what they're lookingfor, uh, without mentioning cost
savings and, and, uh, patientrecruitment potential because of
the size of the, uh, of thecountry, the population.
So I, I will say that, uh, LatinAmerica is getting more and more
mature, uh, countries likeColumbia, like Chile are really,
(06:23):
really making efforts to, tobecome, uh, knowledge economies
versus, uh, commodity exportingor agriculture exporting
countries.
And, and knowledge economiesmeans that you have to, to, to
somehow connect, uh, yourindustries to the world,
especially the service industry,uh, in, in, in the clinical
(06:47):
research is a great, it's just afantastic way of, of connecting
a country to the world to highlevel of, of, of, uh, knowledge
about innovation and all that.
So, so yeah, I will say that,uh, Columbia is offering a lot
more certainty, way morecertainty than Europe or the
United States right now.
Speaker 3 (07:07):
Yeah, absolutely.
Yeah, it's a good summary.
Speaker 2 (07:10):
All right.
So let's, uh, continue.
Um, I heard that, uh, you guysdid a great survey about the
state of the industry.
I'm just so thrilled to, to to,to have you here and to, uh,
speak about it.
I mean, can you elaborate onthat, where you guys, uh, what
you guys, uh, concluded afterreading all those surveys?
Yeah.
Speaker 3 (07:30):
Yeah.
And, and so yeah, we did do asurvey.
We called it the, uh, qualitymanagement and product
development surgery survey, um,uh, the 2022 State of MedTech.
And, uh, you, there were, therewere several, several things
that came out of it.
I guess I should start bysaying, we interviewed 519
quality professionals.
Um, and so when I say 519, um,about 60% of those were quality
(07:54):
and regulatory clinical.
Um, about 26% of those wereproduct development or
engineering.
And then we had a, a smallsliver of manufacturing, and
then, uh, about 11% worthcorporate or executives.
So the majority were quality andregulatory.
Um, that survey, uh, it, itcovered a broad range of topics
and you asked about conclusions,so we'll talk about in just a
minute.
(08:15):
Um, but I also wanna say, weactually just, I think we just
closed, uh, our most recentsurvey as well.
So we, we have about 600 thistime, uh, quality professionals
that we have interviewed.
So we're getting ready for, fornext year.
So that'll be coming up.
Um, we'll definitely let youraudience know when that's out.
As far as the, uh, theconclusions, there were some
(08:36):
interesting findings.
And before I get to conclusions,one of the things that really
stood out was that timing reallymatters.
And, uh, um, to your point withColumbia, um, that's, that's the
thing that I noticed when Italked to, when I looked at the,
the timelines between Brazil,Mexico, and, and Columbia.
Just the, uh, the speed at whichyou could expect to get through
(08:57):
with Columbia was, was prettymind boggling compared to some
of the others.
Um, I mean, it's almost an orderof magnitude, isn't it?
You know, the difference, um, sowhen we looked at the different
classes, so, so class one, classtwo, class three for class three
device, um, on average, well, Idon't know if it's really fair
to take an average, but let,let's use percentages.
(09:19):
The bulk, 47% of, uh, uh, classthree devices, um, for the FDA
took three to five years to getto market.
So that's actually probably alittle bit, I mean, that
actually might even be a littlefast compared to what I was
expecting.
Um, about 23% of those expected,you know, they, they were around
two to three years, um, but themajority are expecting to, to
(09:43):
take longer than five years.
So if you can shave a fi a yearoff of that, totally.
Yeah.
Yeah.
I mean, you sha you, you nowhave 20% faster to market.
20% is huge.
So, um, just timing, timingmatters, you know, and, and we
heard that from several, uh,several different tiers, um,
MedTech professionals as far as,you know, the different things
(10:05):
that we, we heard.
We, um, another thing that welooked at was whether or not,
uh, these medical professionalswere using what kind of tools
they were using, whether they'reusing purpose-built solutions or
, um, you know, uh, just generalpurpose tools.
It was about half and half.
And when we looked at that, theones who were not using, uh,
(10:26):
purpose-built solutions, youknow, something that was
specifically built for theirindustry, um, timing, uh, timing
was affected as well.
So that was interesting.
Um, let me, I'll kind of skip tothe end as far as some, the, the
top four things that we sawhappening.
So as far as, um, uh, the thingsthat we saw was a disconnect
(10:49):
between management and quality,the actual quality, uh,
department.
So there's a disconnect as faras whether or not, um, they were
actually on target or excellingin quality.
So management typically said,no, we're not doing well with
quality.
It was kind of like a, um, uh,the, the majority of them,
(11:10):
whereas a lot of qualitymanagement said, we're doing
pretty good.
So there was a little bit of adisconnect there.
So that was interesting.
You know, something that tothink about, um, when we kind
of, when we kind of did a fewinterviews with some different
people as to why might that bethe case, uh, one of the
thoughts was, well, managementis thinking about two different
things.
You know, the quality may bethinking how many CAPAs are
(11:31):
open, how many CAPAs have beenclosed, uh, whereas quality in
the, the, the upper executivesmight be thinking more along the
lines of something like, um, youknow, how fast are we getting to
market?
Have we produced more revenue?
And, and, you know, what's theoutlook look like?
So that was one of the thingsthat we noticed.
Uh, supplier management wasanother one.
And, um, and I don't know, I, I,again, I, I love hearing from
(11:54):
you Toolio, you know, I know youwere all on our podcast.
And so when I think suppliermanagement, uh, that's one of
the things that I love to, tohear about as far as, you know,
the, the Latin America and howyou've seen some of those
supplier, um, you know, just cuzMedTech companies are gonna call
it a supplier, whoever they are.
But that partnership, um, acrossthose country lines, what have
(12:16):
you seen as far as thatmanagement?
Speaker 2 (12:18):
Well, um,
Speaker 3 (12:20):
Is that something I'm, I'm allowed to ask
Speaker 2 (12:22):
No, no.
Uh oh, it's a good question.
I don't know the answer to behonest with you.
I, I, yeah, I don't, I don't getinvolved.
We don't get involved in, in, inquality issues with our clients.
They just ask us for SOPs, andthat's it.
I mean, we're a US company, sowe are not really, so, no, I
(12:46):
don't, I don't have an answerfor that, to be honest with you.
I'm
Speaker 3 (12:48):
Sorry,
Well, so No, no, that's okay.
And that's okay.
I just like to ask the question.
I don't mean to put anyone onthe spot.
I'm supposed to be the one onthe spot here,
Speaker 2 (12:55):
So,
Speaker 3 (12:57):
Uh, one of
Speaker 2 (12:58):
Speaker 3 (12:59):
Anyway.
Well, you know, when, when Ithink supplier management, you
know, we're going to a remoteworld, you know, and, and that's
inevitable.
But when you talk about certainaspects of your suppliers, there
are certain things that you needto be doing in person.
And I'm, yeah, this is me alittle bit selfishly as a, as a,
as a, you know, a world traveler, traveler, not necessarily by
choice.
My wife has turned me into one.
(13:19):
She, she takes me differentplaces.
And, and that's wonderful.
I'm very thankful for that.
Um, when you choose yoursuppliers, you know, one of the
things you need to think aboutis how close are they?
How can I, can I get to them?
Um, you know, can I have arelationship with them?
And, uh, so you don'tnecessarily think of a country,
you know, at least I don'tnecessarily think, is this
country a place I wanna go tofor that supplier?
(13:40):
But that actually plays into it,um, your relationship with those
things.
So that might be another thingto think about when you're
thinking about your, your longterm
Speaker 2 (13:47):
Suppliers.
Yeah, that, that's a greatpoint.
That's a great point.
And, and, and of course, uh, weoperating in Latin America, and
one of the things from theget-go, we started the company,
we set it up as a UScorporation.
We are a Florida based company.
And that's also to, to give ourclients that level of trust that
(14:08):
you're, they're dealing with alocal supplier, they're dealing
with a US company.
We're a real people in the us.
We're not some remote company inColumbia with a bank account
with a Swift number that takeswhole page
Speaker 3 (14:22):
Right?
Speaker 2 (14:23):
I mean, a whole page of wiring instructions.
You don't know if you're gonnaget your money, these people.
So, so, yeah.
So, so, so, no, it's a greatpoint.
And the word that buffer betweenour clients and our research
centers, uh, not our researchcenter.
I mean, the hospitals that wedeal with are in our network of,
uh, research centers, um, sothey don't have to deal with
(14:46):
foreign suppliers.
So we make it easier for ourclients in, in that way.
Yeah,
Speaker 3 (14:51):
Yeah.
Yeah.
So that's one of the things that, uh, you know, so supplier
management just in general wasone of the things that, um, we
saw quite a few people reallyfelt like was below average.
So actually 75%, 75% felt liketheir supplier quality
management program was belowaverage, or average or below
average.
(15:12):
So that was something to thinkabout.
Um, and, um, yeah, it's just oneof the things that you need to
think about.
Um, another thing to thinkabout.
So one of the other issues withour, you know, when, with that
we found in this survey was oneof the, uh, um, one of the
things that people experience isif you experience a warning
(15:33):
letter, it may take three yearsto reach resolution for that.
Now, I'm, I come from thequality regulatory side, so I, I
think a lot about the quality.
Um, uh, so that's, that's one ofthe things that, um, again, uh,
that uncertainty and starttying, tying it back to that
word that you said, you know,certainty that what you have as
a quality product, what you haveis something that you, uh, you
(15:55):
know, what is going to meet yourexpectations, um, that's
important in the quality world.
Um, because if you, if you don'tcut corners, if things don't
work out the way you expect themto and so forth, um, yeah,
those, those warning letters cantake a long time to resolve.
Yeah,
Speaker 2 (16:09):
Yeah.
I'm sure.
All right.
So, so basically, um, the issueof time is probably the, the,
the issue that we can all helpin Latin America, uh, or the
issue with Latin America can,can, can play a, a predominant,
uh, role for the MedTechindustry, uh, as you correctly
(16:30):
found.
And that's, that's also my, it'sbeen my experience.
That's usually what I hear.
I mean, time, time, time.
How can we start this trialfaster anywhere in Latin
America?
Sometimes I have conversationwhere I have to give them the
whole, my potential client, thewhole framework around the
(16:51):
different countries so that theycan understand where to go and
where they can get their studyapproved faster.
So, so, yeah.
Yeah.
Um, the other thing that I, thatI, I'm very thrilled about is
your acquisition of, um, smarttrials.
Smart trials.
Yes.
That will also save time and,and, and effort in managing
(17:14):
these smaller medical deviceearly disability studies, which
are different from pharmastudies.
So, uh, I think, uh, thepartnership that we have and,
and what we're putting togetherhere is gonna benefit the whole
industry, uh, because we'regonna, uh, uh, solve one of
their pain points.
One of the problem is, which isthe time to take that takes a
(17:37):
device to get to market.
Speaker 3 (17:39):
Yeah.
Uh, not just the time too, butlike you said, the certainty.
Um, the
Speaker 2 (17:43):
Certainty.
Exactly.
Speaker 3 (17:44):
Yeah, exactly.
When you have, uh, clinicaltrials spread over multiple
locations, and, uh, you'retrying to capture all that data,
whether it's on paper orthrough, you know, just however
that's being captured, um,really a solution like smart
trial is, is really the way togo as far as that electronic
data capture.
I mean, it's just, it willincrease your, your certainty
(18:04):
and your ability to, um, justhave a lot of more confidence
in, in what you're actuallyperforming.
So,
Speaker 2 (18:11):
Yes.
Yes.
And, and I guess now with theacquisition of smart trials, uh,
your survey may change a littlebit, may add different questions
or, right, yeah.
Speaker 3 (18:23):
Related
Speaker 2 (18:23):
To clinical research, because, uh, it is really hot
topic nowadays.
Uh, the, the increase in demandthat I, that, uh, that I've seen
this year as beingunprecedented,
Speaker 3 (18:35):
I, I think something I, and I'm curious to see how
it's changed.
I remember one of the numbersfrom your articles actually was,
uh, the increase, what from 2012to 2017 was like 94% increase.
Wasn't that that,
Speaker 2 (18:47):
Right, exactly.
Yes.
And
Speaker 3 (18:48):
That's five years old, so
Speaker 2 (18:50):
Yeah, yeah, yeah.
I mean, every, every week I, Iget at least three new inquiries
in our website about a new studyin, in Latin America.
So definitely there is, there isan issue happening in the United
States.
There's an issue happeningEurope that is, there's a
bottleneck somehow also becauseof Covid, uh, probably because
(19:12):
there is, there is, um, newinvestors who knows
really go this, but it'sprobably a combination of
factors and, and, uh, certainlyLatin America has become a place
to, to, to
Speaker 3 (19:26):
Yeah.
Speaker 2 (19:27):
Help fix this issue of timing.
Yeah,
Speaker 3 (19:29):
Exactly.
That's, that's, you know, it'sfunny, we, we think about the
development of a, you know, amedical device and how much, uh,
you know, a chunk of thatclinical trial is, you know, the
cost of developing that medicaldevice.
You know, some, some studies, Ithink it's, you know, not quite
half per half, uh, the amount ofcost.
(19:50):
But you know, in the,historically it's been in the 30
to 40% range, I think, you know,that's, that's the amount of
money it takes to develop amedical device, um, to put it
through clinical trial.
Um, if I'm not mistaken, youknow, that some of the things I
think I are have been read fromyou, though, you know, are, you
know's like 60% reduction incosts as those
Speaker 2 (20:12):
Clinical trials up to, yes.
I would say, yeah, that's, that,that's, that's kinda accurate.
Um, anywhere between 30 and 60%,I would say.
Uh, I see, uh, especially inColumbia, uh, with the Columbian
peso at a historic, uh, lowversus the US dollar.
And, um, it's just, uh, reallyunbeatable to, to, uh, as a
(20:39):
country, I mean, to buy servicesfrom a hospital in Columbia,
you're gonna get a, a greatbargain, uh, is the second most
value currency after Venezuelaand Argentina, Venezuela were
obvious reasons.
Argentina is a country that isstruggling so much to, to get
ahead, and it's very, uh, yeah,unstable in many ways,
economically, politically, uh,socially, uh, but inflation in
(21:03):
Venezuela and Argentina are just, uh, really, really difficult.
It's, it's, it's just funny.
Um, you, you, you walk thestreets of, uh, Colombia in
Bogota, and, uh, there arepeople selling crafts on the
streets with Venezuelancurrency.
They, they sell hats and theysell purses,
(21:25):
animals
You can, oh, really?
Oh my goodness.
That's how bad.
It's, the issue with clinicalresearch in Venezuela is
interesting.
I'm involved with a hospital inCaras, probably the largest
private hospital in, in, in, inVenezuela.
And, um, we are doing a studywith a, uh, intervention of
(21:48):
cardiologist, one of the top inLatin America.
He's from Caras, and he works atthe hospital, and we're working
on a couple studies in Columbia.
And, uh, he's a proctor of thesponsor for the Saudi Columbia.
And we talk a lot, uh, aboutdoing studies in Venezuela.
But the issue is that Americanscannot travel to Venezuela.
(22:09):
But, uh, Venezuela could be anideal place for clinical
research if American could getvisas and travel to the country,
because it's a, it's a countryof over 45 million people,
something like that.
Uh, Columbia is 53 now, uh, and,um, it's a country that has a
great infrastructure, privateAli Ali, the public
(22:29):
infrastructure is gone.
There's really no private, uh,there's no, there's really no
universal healthcare system oranything like that.
It's all private.
You have to have money.
It's dollarized.
So, so yeah, prices are probablynot as cheap as Columbia, but,
uh, it could represent greatsavings for companies.
And eventually the issue will befixed.
I mean, Americans willeventually be able to travel to
(22:51):
Venezuela.
And, uh, actually the pioneer ofearly feasibility clinical
research in Latin America wasVenezuela, Dr.
Corrado, Caras, like 20 yearsago.
Yeah.
Speaker 3 (23:03):
And you know, when I was first thinking about this,
um, first inhuman and some ofthe clinical trials, uh, one of,
one of the issues that I kind ofthought, well, what about
recruitment?
You know, is it, uh, trulyrepresentative of the same type
of population you might see in a, in America, um, whether it's
diet based, things like that.
And, um, just the abil the, thecountries, you know, really
(23:26):
impressive as far as, you know,having not been there myself,
just the things that I've readand the things I've learned
about it, um, it, it's, it's toa level where, you know, the
same, very similar, um,different stratas of life, I
guess different tier, whetherit's diet or, and so forth.
So, um, that kind of erased oneof the biggest concerns in my
mind when it came to, uh, youknow, clinicals and actually was
(23:48):
a big convincing factor, youknow, in, in my mind that, that
it would be a, an appealingplace to go.
Speaker 2 (23:53):
Exactly.
Yes.
Yeah.
Yeah.
Latin America is veryAmericanized nowadays and, and
hospital infrastructure, the waypeople practice medicine and,
and the lifestyle is veryAmericanized.
And, and, uh, it's just like inthe US it's a mix of cultures.
Yeah.
I mean, countries like, uh,Argentina, I mean, probably the,
(24:15):
the population, uh, mix is, is,is uh, is very similar to the
United States, uh, very European, uh, influence.
And, uh, Colombia is a greatmix.
It's a little bit of everything.
You have Italians, uh, Germans,uh, of course Spanish, uh, in,
(24:38):
in Colombia you have also Asiancommunities.
You have Middle Eastern, uh,population.
So it, it kind of similar to, tothe US in, in a way, and, and,
and whites in the US arebecoming minority
Speaker 3 (24:50):
Yeah, it's true.
It's true.
Speaker 2 (24:53):
It's funny,
Speaker 3 (24:53):
cyclical.
It's just, yeah.
Speaker 2 (24:56):
Yeah.
Exactly.
Speaker 3 (24:58):
Um, so I'm curious about, so you heard kind of my
personal anecdote at thebeginning about, you know, maybe
Columbia or whatever.
I'm curious, um, uh, if youcould tell me your quick snippet
as to why, you know, I should goto Columbia?
Maybe not even necessarily froma clinical standpoint.
I just, um, you know, havingbeen there, you know, the, the,
a native yourself, I'd just loveto hear what you have to say
about it real quick.
Speaker 2 (25:18):
Uh, about what, excuse me about going to
Columbia.
Speaker 3 (25:20):
Yeah.
Just, you know, one of the,like, okay, I'm just imagining I
get off the plane and I'm goingto the hospital, but maybe I
want to do something else.
Oh, I see.
What do you recommend?
What should I do first?
Oh,
Speaker 2 (25:32):
Oh, oh, oh,
Speaker 3 (25:33):
I see, I see.
On a personal note.
Speaker 2 (25:34):
Yeah, on a personal note, well, I, if you go to
Columbia, you have to visitBogota is perhaps one of the,
the, uh, the largestmetropolitan areas of, uh, Latin
America with Mexico City, with,uh, Sao Paolo Buenos airs.
It's kinda at the same level.
(25:54):
Uh, you get out outta theairport, and first of all, the
first, one of the best airports,if not the first, uh, there's a
recent survey on this, um, is inBogota.
El Dorado Airport is perhaps thebest airport in, in, in Latin
America right now.
And, uh, that's a lot to say,but it's, it's brand new, just
(26:14):
impressive airport.
And, um, and the highway thatyou see is really, really
impressive.
It is not, I mean, you feel thatyou are not in a banana
republic, or you feel that youare in a real country.
Right.
And, um, of course, Bogota is acapital city.
And, uh, Bogota is, uh, a placeof about over 10 million people.
(26:40):
It's a large metropolitan area,and, uh, it has one of the best
hospitals in Latin America.
And, uh, the reason for that isbecause the geographic location
of the country is, is kind ofprivilege.
Cause it's, it is the firstcountry in South America, so it,
it, it, everybody from theCaribbean travels to Columbia
(27:01):
for medical care, for advancedmedical care.
Everybody from Central America,Panama, Costa Rica, Hondura,
Nicaragua, they either, eitherchoose to go to Mexico or
Colombia.
Right.
And everybody from the south,everybody from Ecuador or Peru,
uh, well, not so much Peru, butunless you're in the, uh,
(27:23):
northern part of Peru.
But, uh, Ecuador, um, Bolivia,they all travel to Columbia for
medical care.
So, so yeah, it's, um, I wouldsay Bogota managing is a
fascinating city.
Very metropolitan, verymulticultural.
And, um, the other city that isup and coming is perhaps the
(27:45):
fastest growing city in Latin,in, in Columbia, probably one of
the fastest growing cities inLatin America is Barran.
Barran is the largest city inthe whole Caribbean basin after
Miami.
That's a fact that not manypeople know about.
Wow.
So yeah, it's a city of abouttwo and a half, 3 million
people, but it, the area ofinfluence of Barran is about 10
million people.
(28:05):
Cause it covers the wholeCaribbean coast's, the largest
metropolitan area next to, andit's right in the middle.
Um, Santa Marta, it's a smallercity towards the north, and cor,
which everybody knows about, istowards the south.
But, um, Barran is the center,the economic center of the
Columbia, Caribbean coast, andhas a large number of hospitals.
(28:27):
I will say probably there areabout at least 10 high
complexity hospitals in thecity.
So patient recruitment is great.
Speaker 3 (28:34):
That's, that's fantastic.
You know, I, um, community isone of the things that I don't
think about, I don't know thatwe think a whole lot about in
MedTech, you know, just thecommunity in general.
Um, the MedTech itself is kindof a small industry, uh, but if
you go to someplace that's, youknow, I don't know if you try to
go to the Mayo Clinic orwherever else where you're not,
you know, listened to andperhaps at whatever level you're
(28:57):
at, what I'm curious about is,you know, the different
communities within thosehospitals and the ability to, to
have a better relationship withthose.
Um, you know, you, you're kindof a, you, you, you work between
the US and, uh, and, anddirectly with the hospital.
So I'm sure you see and manage alot of that relationship.
But, um, that's one of thethings that I'm interested in
learning a little bit more abouttoo in the future.
(29:17):
Yes.
Speaker 2 (29:18):
So, yes.
Yes, exactly.
about the possibilities ofbringing your technology to
Latin America.
There are, uh, a lot of, um, uh,there are a few hubs of
innovation in the region, andmedical devices are increasingly
now that we can use software asa medical device, you find a lot
(29:42):
more entrepreneurs trying, uh,to do something in this area.
So it's a, it's a, it's a, it'sa slowly growing industry in
Latin America.
I would say Brazil, Columbia, Imean, the, the top five
countries in the region have theneed of a software like, uh,
green, like rural offers qualitymanagement system.
So, so yeah, it would befantastic to translate this
(30:04):
offer to Spanish.
I don't know, uh, if you guyshave plans to do that, but
that's a growing
Speaker 3 (30:09):
Area.
That's fantastic feedback.
Um, yeah, that's, that's areally good point.
I don't know that we do at themoment, but I, I need to check
with my product team.
I should probably keep my mouthshut until I know for sure.
Um, but tho like I said, youknow, if, and I'll, I'll send a
link to that, um, state of 2022report, um, and then eventually
when we have our state of 2023report release, we can, we can
(30:30):
definitely send that your way aswell.
But one of the things that, thatwe saw that I already mentioned
was, uh, just the, the companiesthat don't use those specific
tools, um, to help them get tomarket, whether it's something
like Green Light Guru or smarttrial for their clinical trials,
uh, they, they're moving slowerthan the ones who are, who are
(30:50):
using those purpose-built tools.
And Yeah.
Uh, you know, um, I, I look atit kind of like, you know, as a
mechanical engineer, if I lookback at my past, I, I had the
privilege to work at a companywhere, um, it was a hundred year
old company.
It was in the steel industrybefore I came to MedTech.
Uh, we had four different waysof keeping our drawings.
You know, we had, we had them onpaper.
(31:12):
The, you know, the, the, I can'tremember.
It's a E two, just the massivepieces of paper that people had
hand drawn, which is fantastic.
Um, we had microfilm, we hadindex ideas, and then we had
solid works.
You know, guys like me are like,why are we not using solid works
for everything?
Look, I can do what you do fourdays in five minutes.
And, uh, it's just kind of theway the world, you know, it's
always changing.
(31:33):
And, you know, the companiesthat embrace that change, they,
they just move faster.
So.
Totally.
I agree.
Yeah.
Speaker 2 (31:39):
All right.
At the end, we are close to theend of the show.
Thank you so much for beinghere.
It was a delightfulconversation.
I look forward to being intouch.
Speaker 3 (31:46):
Yeah, fantastic.
Great talking to you, Julio.
Speaker 2 (31:48):
Bye-bye.
Thank you.
Speaker 3 (31:50):
Take care.
Take care.
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